Rusan Pharma, a global leader in addiction treatment and pain management pharmaceuticals, has achieved two significant regulatory milestones for its state-of-the-art manufacturing facility in Kandla Special Economic Zone (SEZ) - Unit II, Gujarat. The facility has received Good Manufacturing Practice (GMP) approval from Australia’s Therapeutic Goods Administration (TGA) and an extended GMP certification from Brazil’s Health Regulatory Agency (ANVISA).
The TGA certification, granted after a rigorous inspection, allows Rusan Pharma to manufacture and supply advanced transdermal patches in the Australian market. These innovative drug delivery systems cater to critical medical needs in pain management and addiction treatment, underscoring the company’s commitment to enhancing patient care.
Dr. Kunal Saxena, Managing Director of Rusan Pharma , expressed pride in the achievement, stating, “We are delighted that our Kandla Unit-II facility has received A1 GMP compliance certification from TGA, Australia. This is the second successful TGA inspection of our facility. With this approval, we are poised to bring specialised formulations like Buprenorphine and Nicotine Transdermal Patches to the Australian market, reinforcing our commitment to innovation and quality in advanced pharmaceutical solutions.”
Simultaneously, the extension of ANVISA’s GMP certification strengthens Rusan Pharma’s position in the Brazilian market. The certification enables the company to expand its product offerings in Brazil with solutions such as Buprenorphine, Donepezil, Lidocaine, and Rivastigmine patches. Dr. Saxena emphasised, “This milestone positions us as a one-stop solution provider for transdermal patches and oral films in Brazil and across LATAM countries. It reflects our dedication to delivering high-quality healthcare solutions globally.”
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